The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
A voice prosthesis is a one-way valve placed into a puncture between the trachea and the esophagus of a user who cannot speak following surgical removal of the larynx (voicebox). The voice prosthesis allows air to flow from the lungs through the trachea and into the esophagus to enable voice/speech. Flanges at both ends of the voice prosthesis retain the prosthesis in the tracheoesophageal puncture. Prior to voice prosthesis insertion, a dilator has been used to prevent the puncture from closing, eliminate leakage of the esophageal content and to dilate the puncture prior to initial insertion and later re-insertion of the voice prosthesis. An exemplary known dilator device is a BLOM-SINGER® tracheoesophageal puncture dilator available from InHealth Technologies, a division of Helix Medical, LLC.
After removal of a surgical catheter or voice prosthesis, the dilator maintains the open fistula. Once inserted, the dilator is taped in place on the neck. This device is then removed after several minutes of dilation. Once the fistula is dilated, it needs to be sized. A voice prosthesis sizer, such as the BLOM-SINGER® voice prosthesis sizer available from InHealth Technologies, a division of Helix Medical, LLC, is placed on an inserter and the device is inserted into the fistula. The sizer is gently withdrawn until resistance is detected indicating that the esophageal collar is seated against the interior wall of the esophagus. The size is then read at the mark closest to the puncture entrance. After sizing, a voice prosthesis is then inserted into the puncture for voicing.
The voice prosthesis dilator and sizer device, according to the principles of the present disclosure, combines the functions of the separate voice prosthesis dilator and the sizer into a single device in order to provide a dilating and sizing function that is gentler on the fistula in that only one insertion is needed rather than two. Furthermore, the device makes the process easier for the clinician having only one device to handle. Furthermore, the use of a single device also reduces the chances for infection.
Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.